innFactory AI Consulting from Rosenheim, Germany advises enterprises across the DACH region on GDPR-compliant integration of medical AI. MedGemma is a specialized open-source model for healthcare - we strongly recommend self-hosting for patient data and careful compliance review under MDR/IVDR and the EU AI Act.
Important Notice
MedGemma is NOT an approved medical device. It must not be used as the sole basis for clinical decisions. All results must be validated by qualified medical professionals.
Key Strengths
Medical Specialization
- Medical text and image understanding for clinical content
- Research and education for documentation and summaries
Open Models for Research
- Open weights to run in your own infrastructure
- Customizable fine-tuning for specific domains
Regulatory Aspects
EU Regulation
- MDR/IVDR: Mandatory compliance for EU deployment
- AI Act: Medical AI classified as high-risk system
- Liability: Full responsibility lies with the user
Data Privacy in Healthcare
- Patient Data: Special protection required under GDPR Art. 9
- Self-Hosting: Strongly recommended for patient data
- Anonymization: Mandatory before any processing
Self-Hosting Recommendation
For medical applications, we strongly recommend self-hosting:
- Patient data never leaves your infrastructure
- Full control over data flows
- Compliance with data protection requirements
- No dependency on external services
Our Recommendation
MedGemma is a valuable tool for medical research and as a support system. It should never be used as the sole basis for clinical decisions.
For healthcare companies, we offer specialized AI consulting - particularly regarding compliance with MDR, IVDR, and the EU AI Act.